FDA sends a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aerosol after the company failed to respond to multip...
FDA warns St. Paul, MN-based HealthPartners Neuroscience Center Research and Innovation about good laboratory practice violations in its conduct of no...
Two Morgan Lewis attorneys explain a new FDA draft guidance on three-year drug exclusivity for new clinical investigations.
Senate appropriators delay consideration of a fiscal 2027 spending bill that would fund FDA, after a broader dispute over a Republican reconciliation ...
FDA issues Cingulate a complete response letter on the company's NDA for CTx-1301, an investigational treatment for attention-deficit/hyperactivity di...
FDA issues an early alert regarding a potentially high-risk problem involving certain Abiomed catheter introducer kits used with the companys Impella ...
FDA warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, facility.
FDA warns Mexicos Laboratorios Jaloma about CGMP violations in its production of finished drugs.
